25 results
·
27ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
INTEGRA TITANIUM BONE WEDGE
FDA 510(k)
FDA Class 2
·Orthopedic
CoRoent
FDA UDI
Nuvasive, Inc.·00887517574701·CoRoent Ant TLIF Ti, 13x11x36mm 0°
PIVOX™ Oblique Lateral Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169605022·SPACER 2131360 OLIF25 27MM 6 DEG 12X60
ArgenIS
FDA UDI
ARGEN CORPORATION, THE·D818131360·TiBase Screw AO RP
OsteoMed
FDA UDI
OSTEOMED LLC·00845694046152·PrimaLIF LLIF PEEK Implant, 13mm X 22mm X 60mm,...
SHEAUMANN PL-980
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GI SUPPLY BILIARY STENT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GMK-PRIMARY FEMUR PS CEMENTED SIZE 6 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·July 16, 2020
EXC ABT RNGLC-X SHELL PC 060MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JDI·March 1, 2021
GMK-PRIMARY FEMUR PS CEMENTED SIZE 4
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·May 22, 2019
GMK-PRIMARY FEMUR PS CEMENTED SIZE 4 LEFT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·August 23, 2017
GMK-PRIMARY FEMUR PS CEMENTED SIZE 6 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 25, 2018
DIAMOND II
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code DXY·June 16, 2011
HEARTMATE II LVAS
FDA Adverse Event
Death
·THORATEC CORPORATION·Product code DSQ·May 23, 2013
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code IOR·October 1, 2014
OT VERIO2 METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 8, 2016
Avex CX Suite, Avex CX 0.22 UL4,5 HK REF #224-017, Product Usage: Avex CX ceramic brackets are formed with 99.9% pure alumina oxide. The indicated use of the Avex CX ceramic bracket is the mechanical movement of natural teeth in conjunction with other components designed to attach to the brackets.
FDA Enforcement
Class III
·Terminated·Ultradent Products, Inc.·March 6, 2013
Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO
FDA Enforcement
Class I
·Ongoing·Abbott Vascular·May 25, 2022
RESOLUTE INTEGRITY RX
FDA Adverse Event
Death
·MEDTRONIC IRELAND·Product code NIQ·October 19, 2018
BIOMET HIP SYSTEM MODULAR HEAD COMPONENT
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·July 19, 2017